Home / Recalls / Medical Devices
Xoran Technologies, Inc. recalls Xoran MiniCAT CT Scanner
Recalled November 6, 2013 · FDA recall Z-0037-2014 · Xoran Technologies
Hazard
A description of the defect in the product or the manner in which the product fails to comply wvith an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evalu · FDA Class II
Units
320
Sold at
Worldwide Distribution - Nationwide
Description
A description of the defect in the product or the manner in which the product fails to comply wvith an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evalu
Product
Xoran MiniCAT CT Scanner
Manufacturer(s)
Xoran Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →